Section 122I in The Drugs and Cosmetics Rules, 1945
122I. Inspection before grant or renewal of license for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products.
- Before a license in [Form 28-C or Form 28-E is granted or a renewal of license in Form 26-G or Form 26-I is made, as the case may be] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).], the licensing authority or the Central License Approving Authority, as the case may be, shall cause the establishment in which blood bank is proposed to be operated/whole human blood for components is processed/blood products are manufactured to be inspected by one or more inspectors, appointed under the Act and/or along with the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/equipments and inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for operation of blood bank/processing of whole human blood for components/manufacture of blood products together with their testing facilities and also enquire into the professional qualification of the expert staff and other technical staff to be employed.
